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Cervical Stiffness Measurement in Cervical Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158401
Recruitment Status : Completed
First Posted : November 8, 2019
Last Update Posted : September 21, 2022
Sponsor:
Collaborator:
Pregnolia AG
Information provided by (Responsible Party):
Tufts Medical Center

Study Description
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Brief Summary:

The goal of this cross sectional study is to evaluate the differences in cervical stiffness between patients who present for cerclage placement versus normal pregnancies.

The central hypothesis is that women for whom a cerclage is indicated will have cervical stiffness measurements lower than normal controls. Cervical stiffness will be objectively measured by the closing pressure Pcl using the Pregnolia measurement device. This is performed during a speculum exam by placing the measurement probe on the ectocervix.

In current clinical care, there is no objective measurement of cervical stiffness. An accurate measurement of cervical stiffness that correlates with clinical outcome will advance the field. Successful completion of the current study will spark future studies that correlate cervical stiffness pcl in a prospective study.


Condition or disease Intervention/treatment
Pregnancy Related Cervical Insufficiency Preterm Birth Device: Pregnolia

Study Design
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Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cervical Stiffness Measurement in Cervical Insufficiency
Actual Study Start Date : January 15, 2020
Actual Primary Completion Date : June 15, 2022
Actual Study Completion Date : June 15, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Control group
Pregnant patients between 12w0d and 22w0d who present for prenatal care.
 Device: Pregnolia
The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.
Cerclage group A
Patients who present for a history-indicated cerclage placement.
 Device: Pregnolia
The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.
Cerclage group B
Patients who present for an ultrasound-indicated cerclage placement.
 Device: Pregnolia
The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.
Cerclage group C
Patients who present for an exam-indicated cerclage placement.
 Device: Pregnolia
The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.


Outcome Measures
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Primary Outcome Measures :
  1. Cervical stiffness (Pcl) [ Time Frame: 5 minutes ]
    The primary outcome will be cervical stiffness, Pcl in patients presenting for cerclage versus normal controls.


Secondary Outcome Measures :
  1. Delivery data [ Time Frame: up to 10 months ]
    Patient delivery data including gestational age, mode of delivery and complications will be recorded

  2. Newborn outcomes [ Time Frame: up to 10 months ]
    Newborn outcomes including weight, APGARs and complications will be recorded


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients need to be pregnant.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
We are studying pregnant patients between 12w0d and 22w6d.
Criteria

Inclusion Criteria:

  1. Pregnant women over 18 years of age.
  2. Singleton gestation.
  3. Gestational ages between 12w0d and 22w6d.
  4. Candidates for cerclage
  5. Normal controls, which will be matched to cerclage subjects by gestational age and parity

Exclusion Criteria:

  1. Multiple gestation pregnancy.
  2. Pregnancy complications: Premature rupture of membranes, Placental abruption, Placenta previa/accreta.
  3. Chorioamnionitis
  4. Preterm contractions
  5. History of cervical surgery (LEEP, trachelectomy, conization).
  6. Mullarian anomaly
  7. Known carrier or HIV or Hepatitis B/C
  8. Active genital infection
  9. Communication problems (cognitively impaired adults unable to give consent)
  10. Cerclage placement already performed this pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158401


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02122
Sponsors and Collaborators
Tufts Medical Center
Pregnolia AG
Investigators
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Principal Investigator: Michael House, MD Tufts Medical Center
More Information
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Publications:

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT04158401    
Other Study ID Numbers: 13549
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Uterine Cervical Incompetence
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Uterine Cervical Diseases
Uterine Diseases
Abortion, Habitual
Abortion, Spontaneous